Diagnostic Tests

News & Analysis as of

Insurance Recovery Law - June 2014

Lab’s “Body Bag” Presentations Triggered Coverage For Defamation Claims: Why it matters - We’ve all sat through some pretty boring PowerPoint presentations. But the lesson from a recent decision: it might be a...more

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

Recent District Court Case Highlights State Variation in Applying Corporate Practice of Medicine and Global Billing Restrictions...

On March 25, 2014, the U.S. District Court for the District of Minnesota held that a magnetic resonance imaging ("MRI") provider, a lay entity (i.e., not owned or controlled by physicians), did not violate the state's...more

Personalized Medicine and Patent Eligibility under 35 U.S.C. § 101

Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more

Patent Profile: National Tsing Hua University Receives Patent for Method for Early Diagnosis of Liver Cancer

Last week, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,628,920, which is entitled "Method for early diagnosis of liver cancer and prediction of metastasis." The '920 patent, which is assigned to National...more

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

Salient Lessons For Australian Applicants Of US Diagnostic Patent Applications

In the latest decision concerning diagnostic method claims a US Court1 has provided some guidance to the diagnostics industry on the interpretation of the recent Supreme Court decisions in Mayo v Prometheus2 (Mayo) and AMP v....more

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics

Myriad is facing yet another challenge to its remaining BRCA gene testing franchise, this time from Quest Diagnostics joined by its R&D arm, Nichols Institute. Quest is "the world's leading provider of diagnostic information...more

Failure To Comply With Physician Supervision Requirements Can Be Costly

The Department of Justice recently announced two large settlement agreements with provider organizations and individual physicians based on failure to provide proper physician supervision for diagnostic imaging and radiation...more

Risk-Sharing and Reimbursement of Diagnostic Tests

Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more

2013-2014: Evolving Challenges for Value-Priced LDTs

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

BIO IPDx Symposium Highlights Uncertainty in Diagnostic Patenting

On July 22, BIO hosted the first IP and Diagnostics (IPDx) Symposium in Alexandria, Virginia, which was organized to open a dialogue regarding the latest developments in diagnostics and personalized medicine. The symposium...more

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more

Are Hospitals Safer Today? Why Patient Safety Levels Remain Static

We have entered a new era in medical technologies. From electronic patient charts to robotic surgeries, hospitals have become more advanced in the types of care they provide. Despite a multitude of technological and...more

Courts of Appeals Continue to Limit the Government’s Aggressive False Claims Act Theories

This spring saw two significant victories for health care providers in the federal courts of appeals. In both cases, the courts rejected an aggressive government theory under the False Claims Act (FCA), the first related to...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

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